摘要
目的为我国医疗器械科学监管提供技术支持。方法对国内外医疗器械分类法规及近年来我国医疗器械产品分类界定申请资料进行研究分析。结果与结论借鉴国外先进经验,提出完善我国医疗器械分类法规和医疗器械分类数据库等建议,使医疗器械分类界定更加科学合理。
Objective To provide technical supports for scientific supervision of medical devices in China. Methods Application materials for medical device classification in recent years in China and classification regulations at home and abroad were studied and analyzed. Results and Conclusion By reference to the advanced experience abroad, some suggestions were put forward on perfecting classification regulations and databases in China so as to make the medical device classification more scientific and rational.
出处
《中国药事》
CAS
2013年第6期561-563,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
分类
法规
medical devices
classification
regulation
